Will Claritin Be Sold Without A Prescription?

Schering-Plough
will already face generic competition on Claritin, its blockbuster antihistamine, as early as the end of this year. But now it's starting to look like Claritin may not merely go generic, but will also be sold over the counter. A non-prescription version of the drug would hurt Schering and other companies that make antihistamines.

Schering-Plough
Schering's Clarinex Goes On Sale
Yesterday morning, Schering
said it was suing the generic drug divisions of
American Home Products
and
Johnson & Johnson
. It says it believes that both companies are filing to sell generic, over-the-counter versions of Claritin.

In a highly unusual move earlier this year, the Food and Drug Administration recommended, in response to a request brought by insurance companies, including
WellPoint Health Networks
, that Claritin and competing drugs Allegra, made by
Aventis
, and Zyrtec, made by
Pfizer
, should be available over the counter.

"If there was one message that I gleaned from the advisory committee," says Robert Hazlett, an analyst at Robertson Stephens, "it wasn't that they were going to force things, but that the FDA would be receptive to a direct generic over-the-counter application. The fact that these companies are doing that is not surprising at all."

When it went on sale, Claritin was the only non-sedating, once-a-day antihistamine on the market. Schering has spent millions marketing the drug directly to consumers and built it into a $3 billion-a-year drug.

The main compound patent on Claritin expires in December of this year. Although Schering-Plough says it has other patents on the drug that could extend the drug's life for more than a decade, most analysts expect these won't hold. Generic Claritin is expected by the end of the year--at the very least that will cut Claritin sales in half.

If Claritin is sold over-the-counter, the damage could be even greater. It could extend to other members of the antihistamine class. Hazlett says he expects some players, like
Sepracor
, which is developing Soltara, a non-sedating antihistamine that appears to start working faster than Claritin, should be able to survive the threat. "If you have a differentiated drug," Hazlett says, "I think you're still going to be able to sell it."

The biggest problem may be for Schering itself. A month ago, it received approval for Clarinex, a follow-up to Claritin. Investors hope that it can switch Claritin users to Clarinex during this year's spring allergy season. But many are doubtful.

Claritin, remember, was sold as a once-a-day drug. But now Schering is saying it has had concerns that the drug didn't actually alleviate allergy symptoms for a full 24 hours. Clarinex, Schering says, does work for a full 24 hours.

That seems like an awfully slim advantage to sell doctors on a new drug, especially if patients can walk into a store and pick up Claritin with no prescription.